Closure or Withdrawal of Research

Purpose

The purpose is to outline the policies and procedures for closure or withdrawal of human research projects.

Definitions

Closure of a research project is an official action taken by the Institutional Review Board or Exempt Review Committee (ERC) to finalize its IRBNet history and to set a date of destruction for all electronic and hard copy records maintained by the Office of Research and Sponsored Programs (ORSP).

De-identification means the removal or separation of any and all identifiers, or any other unique items of individually identifying information, from records or specimens.

Identifiable means the identity of the subject is known or may be readily ascertained by the investigator or associated with the information.

Closure: Only data analysis will continue, but all data are completely de-identified, and no identifying links or codes to the de-identified data exist;

Closure: The PI never initiated the study even though it was approved;

Closure: The PI plans to leave the University and intends to continue the research activities at another institution; or

Withdrawal: The PI is abandoning the project after it has received initial review, but before approval is granted.

Note: Some pieces of information that may not appear to be identifiable in and of themselves may be combined to create new data that could potentially identify a research subject (e.g., person over 85 in a singular zip code; combination of exact birth date within a zip code, etc.).

To close or withdraw a project, the PI must submit a final status report form to the IRB or ERC requesting the action and providing a description of the results or the reason for withdrawal.

If a PI is closing a project because the only remaining activities involve analysis of de-identified data, the PI must explain exactly how the data are no longer identifiable so that closure may be considered.

If a faculty, staff or student investigator separates from the institution while a project is still underway, but activities are limited to data analysis of de-identified data only, the PI must close the project, as Marywood University is no longer responsible for its oversight.

Procedures

Closure Due to PI’s Submission of Final Status Report

When a study nears its projected end date, IRBNet generates an automated e-mail message, which is sent to the PI at 90 days, 60 days, 30 days, and 10 days prior to expiration, as well as one day after. This reminder indicates the date of expiration.

The PI completes the final status report and submits it to the appropriate board or committee through IRBNet.

An ORSP staff member administratively reviews the submission. If questions arise, the staff member will contact the PI; otherwise, the project is marked as closed in the IRBNet system.

Upon closure, an ORSP staff member codes the protocol records as closed in the appropriate database. The ORSP staff member moves the protocol file from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed.

If the PI is closing the project because the only activity which remains is analysis of de-identified data, the PI must explain exactly how the data are no longer identifiable so that closure may be considered.

Closure Due to PI’s Separation from University (Analysis of De-Identified Data Only)

The PI completes the final status report and submits it to the appropriate board or committee through IRBNet.

An ORSP staff member administratively reviews the submission. If questions arise, the staff member will contact the PI; otherwise, the project is marked as closed in the IRBNet system.

Upon closure, an ORSP staff member codes the protocol records as closed in the appropriate database. The ORSP staff member moves the protocol file from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed.

Withdrawal Due to PI’s Non-Response to Requested Modifications

If, after initial review, the PI fails to respond to the IRB or ERC’s request for additional information or modifications within a reasonable amount of time from the date of the last decision letter published in IRBNet (usually between 2-3 months), an ORSP staff member reminds the PI that the IRB/ERC never approved the study and had requested modifications to the submission.

If the PI does not respond within six months of the published decision letter, an ORSP staff member attempts further contact, including via telephone. If a response is not received within 2 days of attempted contact, an ORSP staff member creates a “Special Project Package” in IRBNet so that the IRB can take an official action separate from the initial package’s action.

An ORSP staff member administratively withdraws and permanently closes the project file immediately after the status is changed in IRBNet.

Upon closure, an ORSP staff member codes the protocol records as closed in the appropriate database. The ORSP staff member moves the protocol file from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed.

Closure Due to Expired Approval and PI’s Non-Response to Requests for Final Report or Continuing Review

When an approved study nears its projected end date, IRBNet generates an automated e-mail message, which is sent to the PI at 90 days, 60 days, 30 days, and 10 days prior to expiration, as well as one day after. This reminder indicates the date of expiration.

If the PI does not respond after the fourth automated message is sent (10 days prior), an ORSP staff member notifies the PI by email. If there’s still no response after two working days, the staff member places a follow-up telephone call.

If there is no response as of the expiration date, an ORSP staff member creates a “Special Project Package” in IRBNet so that the IRB can take an official action separate from the last package’s action. The staff member permanently closes the project file.

Upon closure, an ORSP staff member codes the protocol records as closed in the appropriate database. The ORSP staff member moves the protocol file from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed.

PI Initiated Withdrawal

If, after initial review has been conducted and a decision letter has been published, the PI decides that s/he no longer wishes to pursue approval and wants to abandon a project, s/he submits a final status report to the appropriate board or committee through IRBNet.

An ORSP staff member administratively reviews the submission. The project is marked as withdrawn and closed in the IRBNet system.

Upon closure, an ORSP staff member codes the protocol records as withdrawn and closed in the appropriate database. The ORSP staff member moves the protocol file from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed.